NICE backs Keytruda for first and second-line use

MSD’s Keytruda has now become the first and only immunotherapy to be recommended by the National Institute for Health and Care Excellence as a first and second line treatment for specific populations of patients with lung cancer.

A final appraisal determination issued by the Institute is now recommending use of Keytruda (pembrolizumab) within the Cancer Drugs Fund (CDF) as an option for untreated PD-L1-positive metastatic non-small-cell lung cancer (NSCLC) in adults, following an initial rejection earlier this year.

However, the drug is only recommended if tumours express PD-L1 with at least a 50 percent tumour proportion score and have no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK)-positive mutations; Keytruda is stopped at two years of uninterrupted treatment and no documented disease progression; and the conditions in the managed access agreement are followed.

The NICE decision to include Keytruda in the CDF shows that it believes the drug may have the potential to satisfy the criteria for routine use on the NHS for this group of NSCLC patients but needs more data to make a final decision, said MSD.

"This is fantastic news for those people with non-small cell lung cancer that has spread. For the quarter of patients which are suitable for first-line pembrolizumab, it significantly improves survival without significantly impacting the quality of life of patients,” noted Gary Middleton, professor of Medical Oncology at the University of Birmingham.

“NICE's decision means that people are now able to access pembrolizumab at the point that is right for them, thus leading to better patient outcomes" he added.

The recommendation is based on data from the KEYNOTE-024 trial, which showed that Keytruda cut the risk of disease progression or death by 50 percent compared to chemotherapy. The drug also improved overall survival, with a 40 percent reduction in death compared to chemotherapy.

“In 2016 patients began accessing pembrolizumab as a first-line lung cancer treatment under the Early Access to Medicines Scheme. MSD UK is really pleased with today’s NICE recommendation which will see us working with the Cancer Drugs Fund so that patients can continue to access pembrolizumab as we further build our knowledge of its longer-term outcomes for patients,” said Louise Houson, UK Managing Director of MSD.

Keytruda was previously backed by the Institute as a treatment option for patients with advanced NSCLC who had failed chemotherapy and who expressed the PD-L1 biomarker at any level (>1 percent) in guidance published in January this year.

Lung cancer is the third most common cancer in the UK, with more than 46,000 new cases diagnosed in 2014. The disease is the leading cause of cancer-related mortality in the country and has a particularly bleak prognosis, with just 5 percent of patients surviving the condition for ten or more years.